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NCT02076126 Clinical Trial

Determination of Lung Maturity and Prediction of RDS at Birth

Premature Birth Clinical Trial

Official title:
Spectroscopic-chemometric Determination of Lecithin-sphingomyelin Ratio in Gastric Aspirates and Secretion From Hypopharynx at Birth, in Relation to Development of RDS

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02076126
Other study ID # Holb.SJ-384
Secondary ID
Status Completed
Phase N/A
First received February 28, 2014
Last updated January 29, 2015
Start date March 2014
Est. completion date January 2015

Study information
Verified date January 2015
Source Holbaek Sygehus
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics Committee
Study type Observational

Clinical Trial Summary

The overall objective is to identify quickly after birth the preterm infants who will develop respiratory distress syndrome (RDS) for the purpose of treating them as early as possible with surfactant, to reduce, and if possible, to avoid sequelae, including long-term oxygen treatment.

We have therefore developed a quick test, which we believe will be ideal for this type of diagnostics, and will now test the method in a preclinical trial.

Description:

In at least 135 preterm infants with gestational age 24-32 weeks we will collect gastric aspirate and hypopharyngeal secretion. The infants are stratified into three groups: gestational age 24-25 weeks, 26-29 weeks and 30-31 weeks.

The aspirates will be frozen at -20 centigrade and lecithin-sphingomyelin ratio (L/S) will be analysed retrospectively using Fourier Transform Infrared Spectroscopy.

The infants will be monitored for the first five days with regard to possible development of RDS.

Clinical and biochemical data will be compared retrospectively.

There a no intervention procedures.

Recruitment information / eligibility
Status Completed
Enrollment 145
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group N/A to 30 Minutes
Eligibility Inclusion Criteria:

- Preterm infants with gestational ages of 24 (24+0) to 32 (31+6) weeks.

- Age < ½ hour

Exclusion Criteria:

- Lack of informed consent

- lack of aspirate

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
Denmark Holbaek Sygehus Holbaek

Sponsors (12)
Lead Sponsor Collaborator
Henrik Axel Verder Aalborg Universitetshospital, Aarhus University Hospital Skejby, Copenhagen University Hospital at Herlev, Holbaek Sygehus, Hvidovre University Hospital, Kolding Sygehus, Naestved Hospital, Odense University Hospital, Rigshospitalet, Denmark, Skane University Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary RDS 5 days No
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